other material
confidence high
sentiment positive
materiality 0.55
OpGen signs non-exclusive distribution deal with Fisher Healthcare for Unyvero platform in U.S.
CapForce Inc.
- Fisher Healthcare becomes non-exclusive national distributor for Unyvero A50 platform alongside OpGen's direct U.S. sales.
- Initial focus on FDA-cleared Unyvero LRT (BAL) cartridge for hospitalized pneumonia patients and RUO Unyvero UTI for UTIs.
- Unyvero LRT is first FDA-cleared IVD for bacterial pneumonia and antimicrobial resistance markers.
- Unyvero UTI pivotal trial completed; De Novo classification request submitted to FDA.
- Deal aims to expand Unyvero commercial presence and drive revenue growth in the U.S.